Trial Outcomes & Findings for Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity (NCT NCT00247377)
NCT ID: NCT00247377
Last Updated: 2023-04-24
Results Overview
weight loss as measured by change in percent of excess body weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
Baseline to 5 years
Results posted on
2023-04-24
Participant Flow
recruitment between 2002 and 2007 in our bariatric surgery clinic
Patients were excluded because they did not want to undergo the randomized assignment or inability to obtain insurance coverage for the operation
Participant milestones
| Measure |
Laparoscopic Gastric Bypass
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
86
|
|
Overall Study
COMPLETED
|
111
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Baseline characteristics by cohort
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
197 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
45.8 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
43.6 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
86 participants
n=4 Participants
|
197 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 yearsPopulation: Availability of subjects and protocol design
weight loss as measured by change in percent of excess body weight
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Excess Weight Loss From Pre-operation to 5 Years Post-operation
|
68.4 percent change
Standard Deviation 19.5
|
45.4 percent change
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response where 0 is non-functioning and 100 is fully functioning
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
86.8 units on a scale
Standard Deviation 14.2
|
93.1 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: date of surgeryoperative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Cost of Procedure to the Medical Facility on Date of Procedure
|
12310 dollars per patient
Standard Deviation 3099
|
10767 dollars per patient
Standard Deviation 1631
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
88.2 units on a scale
Standard Deviation 12.5 • Interval 0.0 to 100.0
|
100.0 units on a scale
Standard Deviation 0 • Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
81.1 units on a scale
Standard Deviation 28.8
|
84.5 units on a scale
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
82.7 units on a scale
Standard Deviation 18.1
|
85.3 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
73.2 units on a scale
Standard Deviation 22.4
|
71.3 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
92.8 units on a scale
Standard Deviation 12
|
81.3 units on a scale
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
|
82.5 units on a scale
Standard Deviation 47.6
|
100 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthschange in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being
Outcome measures
| Measure |
Laparoscopic Gastric Bypass
n=111 Participants
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 Participants
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation
|
83.6 units on a scale
Standard Deviation 14.1
|
86 units on a scale
Standard Deviation 14.3
|
Adverse Events
Laparoscopic Gastric Bypass
Serious events: 36 serious events
Other events: 32 other events
Deaths: 0 deaths
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Serious events: 12 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laparoscopic Gastric Bypass
n=111 participants at risk
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 participants at risk
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal hemorrhage
|
1.8%
2/111 • Number of events 2 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
gastrointestinal obstruction
|
3.6%
4/111 • Number of events 4 • 2002-2007
|
1.2%
1/86 • Number of events 1 • 2002-2007
|
|
Injury, poisoning and procedural complications
internal herniation
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
General disorders
anastomotic stricture
|
15.3%
17/111 • Number of events 17 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Injury, poisoning and procedural complications
internal hernia
|
1.8%
2/111 • Number of events 2 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Injury, poisoning and procedural complications
ventral hernia
|
2.7%
3/111 • Number of events 3 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Injury, poisoning and procedural complications
death related to alcohol
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
marginal ulcer
|
1.8%
2/111 • Number of events 2 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
abdominal pain requiring laparoscopy
|
1.8%
2/111 • Number of events 2 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
bowel obstruction
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Nervous system disorders
peripheral neuropathy
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Renal and urinary disorders
renal insufficiency
|
0.00%
0/111 • 2002-2007
|
1.2%
1/86 • Number of events 1 • 2002-2007
|
|
Surgical and medical procedures
anastomotic leak
|
0.00%
0/111 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Surgical and medical procedures
port revision
|
0.00%
0/111 • 2002-2007
|
3.5%
3/86 • Number of events 3 • 2002-2007
|
|
Surgical and medical procedures
band erosion/slippage erosion
|
0.00%
0/111 • 2002-2007
|
5.8%
5/86 • Number of events 5 • 2002-2007
|
|
General disorders
failure of weight loss requiring revision of anastomosis
|
0.00%
0/111 • 2002-2007
|
2.3%
2/86 • Number of events 2 • 2002-2007
|
Other adverse events
| Measure |
Laparoscopic Gastric Bypass
n=111 participants at risk
Laparoscopic Gastric Bypass instead of LAP-Band
|
Laparoscopic Adjustable Gastric Banding (LAP-BAND)
n=86 participants at risk
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration require readmission
|
3.6%
4/111 • Number of events 4 • 2002-2007
|
1.2%
1/86 • Number of events 1 • 2002-2007
|
|
Renal and urinary disorders
Urinary tract infection
|
1.8%
2/111 • Number of events 3 • 2002-2007
|
1.2%
1/86 • Number of events 3 • 2002-2007
|
|
Respiratory, thoracic and mediastinal disorders
Clinically significant atelectasis
|
0.00%
0/111 • 2002-2007
|
1.2%
1/86 • Number of events 1 • 2002-2007
|
|
Infections and infestations
Wound infection
|
6.3%
7/111 • Number of events 7 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
Prolonged Diarrhea
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Infections and infestations
Clostridium difficile infection
|
0.90%
1/111 • Number of events 2 • 2002-2007
|
1.2%
1/86 • Number of events 2 • 2002-2007
|
|
Gastrointestinal disorders
Ileus
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal ulcer
|
8.1%
9/111 • Number of events 9 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.8%
2/111 • Number of events 2 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Metabolism and nutrition disorders
Severe iron deficiency requiring iron infusion
|
2.7%
3/111 • Number of events 3 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
|
Social circumstances
Alcohol Abuse
|
0.90%
1/111 • Number of events 1 • 2002-2007
|
0.00%
0/86 • 2002-2007
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place